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Sr. Principal Human Factors Engineer (Medical Device)

Company: Alcon
Location: Lake Forest
Posted on: January 11, 2021

Job Description:

Responsibilities:* This position has a significant impact to the business as the key role responsible for the Human Factors Engineering function for the surgical instrumentation franchises.* This a specialized skillset that is needed by product teams to ensure optimal usability characteristics and use safety of current and future Alcon products.* This role is needed to support the development of world-class products, and to meet the requirements of medical device regulatory agencies around the world.* This position serves to identify, define, analyze, validate and report on Human Factors Engineering and Usability considerations to ensure they are incorporated in the design process related to Alcon products.* The position also involves advocacy for end users through the conduct of interviews or surveys of users or customers to collect information on topics such as use-related requirements, use risks, needs, user profiles, task analysis and user interfaces.* Additionally, the position involves needs assessment of the user-interface elements and usability characteristics of both current and future Alcon products, with special emphasis on aspects related to use safety.* Ensure user needs and requirements are translated into design concepts.* Plan and conduct usability evaluations, analyze data, document results, and present recommendations to product teams.* Create documentation related to human factors activities needed for regulatory compliance.* Collaborate with multi-disciplinary teams, including engineering, marketing, regulatory, and clinical areas.**Relocation Assistance is available for this role.**Minimum Qualifications:* Bachelor's Degree or equivalent years of directly related experience (or high school+15 yrs; Assoc.+14 yrs; M.S.+7 yrs; PhD+6 yrs)* The ability to fluently read, write, understand and communicate in English* 7 Years of Relevant ExperiencePreferred Qualifications:* Bachelor's degree in Engineering, Science or Psychology (Usability Engineering, Cognitive/Experimental Psychology)* Excellent written and verbal English communication skills are required.* Demonstrated work experience in relevant industry* Proven ability to develop/implement design input requirements, verification/validation plans, advanced processes and techniques related to human factors engineering and usability* Experience in safety-critical industry where Human Factors Engineering is required by regulations* Demonstrated ability to provide technical direction with proven results* Working knowledge of state-of-the-art clinical procedures or technical processes* Recognized by peers and management as a specialist* Demonstrated work experience in relevant industry* Demonstrated ability to create Human Factors Plans that meet both the business objectives and compliance with the relevant regulatory standards.* Demonstrated experience of conducting Human Factors Summative Studies and successful regulatory approvals (example, 510K)* Experience in managing external Human Factors vendors* Working knowledge of IEC/ISO 14971* Working knowledge of IEC/ISO 62366-1:2015, 62366-2:2015, FDA guidelines for Human Factors and Usability Engineering, and AAMI HE75:2013Alcon is an Equal Opportunity Employer and participates in E-Verify. Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to and let us know the nature of your request and your contact information.

Keywords: Alcon, Lake Forest , Sr. Principal Human Factors Engineer (Medical Device), Engineering , Lake Forest, California

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